Double-Blind, Parallel, Randomised Study to Investigate the Effect of Oral Probiotics in Infants With Atopic Dermatitis
NCT ID: NCT00224432
Last Updated: 2006-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2001-03-31
2002-09-30
Brief Summary
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Detailed Description
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* To determine the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological reactivity to cow' milk challenge in infants with AD with CMA
* To compare the effectiveness of different strains of probiotic bacteria in improving clinical and immunological outcome in these infants
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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probiotics: Lactobacillus GG, lactobacillus Rhamnosus
Eligibility Criteria
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Inclusion Criteria
* Suggestive of CMA (one additional symptom)
* Scorad index (total) \>20 at study entry
* Below 5 months of age
* Formula, not breast fed
* Written informed consent from the parents
Exclusion Criteria
* Use of systemic antibiotic or anti-mycotic drugs in the previous 4 weeks
* Congenital intestinal abnormality (eg. Hirschsprung's disease, intestinal atresia)
* Other GI disease with intestinal inflammation and/or increased intestinal permeability
* Skin disorder, not atopic dermatitis
* Participation in another clinical study
0 Years
5 Months
ALL
No
Sponsors
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Numico Research Wageningen, the Netherlands
UNKNOWN
Groningen Research Institute for Asthma and COPD
OTHER
Principal Investigators
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Eric J Duiverman, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dept of Pediatric Pulmonology, University Medical Center Groningen, The Netherlands
Marianne L Brouwer, MD
Role: PRINCIPAL_INVESTIGATOR
Dept of Pediatric Pulmonology, University Medical Center Groningen, The Netherlands
Locations
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Beatrix Children's Hospital, University Medical Center Groningen
Groningen, , Netherlands
Countries
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References
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Brouwer ML, Wolt-Plompen SA, Dubois AE, van der Heide S, Jansen DF, Hoijer MA, Kauffman HF, Duiverman EJ. No effects of probiotics on atopic dermatitis in infancy: a randomized placebo-controlled trial. Clin Exp Allergy. 2006 Jul;36(7):899-906. doi: 10.1111/j.1365-2222.2006.02513.x.
Other Identifiers
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METc/99/07/116
Identifier Type: -
Identifier Source: org_study_id